[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.42]
[Page 226-227]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 21 PROTECTION OF PRIVACY--Table of Contents
Subpart D Procedures for Notification of and Access to Records in
Privacy Act Record Systems
Sec. 21.42 Responses to requests.
(a) The FDA shall respond to an individual's request for
notification as to whether a Privacy Act Record System contains records
about him that are retrieved by his name or other personal identifier by
sending a letter under this paragraph.
(1) If there are no records about the individual that are retrieved
by his name or other personal identifier in the named Privacy Act Record
System, or the requester is not an ``individual'' under Sec. 21.3(a),
the letter shall so state. Where appropriate, the letter shall indicate
that the Food and Drug Administration's public information regulations
in part 20 of this chapter prescribe general rules governing the
availability of information to members of the public, and that a request
may be made in accordance with part 20 of this chapter for records that
are not retrieved by the requester's name or other personal identifier
from a Privacy Act Record System.
(2) If there are records about the individual that are retrieved by
his name or other personal identifier and the named Privacy Act Record
System is not exempt from individual access and contest under Sec.
21.61, or the system is exempt but access is allowed or required under
Sec. 21.65, the letter shall inform him that the records exist and
shall either:
(i) Enclose a copy of the records under Sec. 21.43(a)(1) or
indicate that the records will be sent under separate cover, where there
has been adequate verification of the identity of the individual under
Sec. 21.44 and the fees under Sec. 21.45 do not exceed $25, or
(ii) Inform the individual of the procedures to obtain access to the
records by mail or in person under Sec. 21.43(a)(2), as well as the
approximate dates by which the requested records can be provided (if the
records are not then available), the locations at which access in person
may be had, and the information needed, if any, to verify the identity
of the individual under Sec. 21.44.
(3) If the named Privacy Act Record System contains records about
the individual that are retrieved by his name or other personal
identifier, and the system is exempt from individual access and contest
under Sec. 21.61 and access is not allowed or required under Sec.
21.65, the letter should inform him that the records are exempted from
access and contest by Sec. 21.61. The letter shall also inform him if
the records sought are not available because they were compiled in
reasonable anticipation of court litigation or formal administrative
proceedings or are otherwise not available under Sec. 21.41(b). Where
appropriate, the letter shall also indicate whether the records are
available under part 20 of this chapter (the public information
regulations), and it may disclose the records in accordance with part
20.
(4) If the named Privacy Act Record System contains records about
the individual that are retrieved by his name or other personal
identifier, but a final determination has not yet been made with respect
to disclosure of all of the records covered by the request, e.g.,
because it is necessary to consult another person or agency having an
interest in the confidentiality of the records, the letter shall explain
the circumstances and indicate when a final answer will be given.
(b) Except as provided in Sec. 21.32, access to a record may only
be denied by the Associate Commissioner for Public Affairs or his or her
designate. If access to any record is denied wholly or in
[[Page 227]]
substantial part, the letter shall state the right of the individual to
appeal to the Commissioner of Food and Drugs.
(c) If a request for a copy of the records will result in a fee of
more than $25, the letter shall specify or estimate the fee involved.
Where the individual has requested a copy of any records about him and
copying the records would result in a fee of over $50, the Food and Drug
Administration shall require advance deposit as well as payment of any
amount not yet received as a result of any previous request by the
individual for a record about himself, under this subpart or part 20 of
this chapter (the public information regulations) before the records are
made available. If the fee is less than $50, prepayment shall not be
required unless payment has not yet been received for records disclosed
as a result of a previous request by the individual for a record about
himself under this subpart or part 20 of this chapter.
[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981]
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